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The PI decides to stop.
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It is a single-center, open-labeled, single-arm, non-randomized investigator-initiated trial evaluating the efficacy and safety of anti-CD19 U-CAR-NK Cells Therapy combined with HSCT for B cell hematologic malignancies.
Who can participate? Patients who were diagnosed with B cell hematologic malignancies and tumor cells expressing CD19.
How to conduct this study? This study is an interventional clinical study. The intervention in the trial is anti-CD19 U-CAR-NK cells, which belong to chimeric antigen receptor modified NK cells. The administration time is 1-7 days after hematopoietic stem cell infusion. Patients were then evaluated for long-term efficacy and safety until 2 years after U-CAR-NK cells infusion.
What are the possible benefits and risks of participating? Benefits: The Dual effect of anti-tumor and anti-infection of NK cells may be used to promote the engraftment of hematopoietic stem cell and better disease control.
Risks: Subjects may have adverse reactions to the treatment. These adverse reactions may include abnormal liver injury, fever, thrombocytopenia, thrombotic microangiopathy, and possibly other unknown adverse reactions.
Where is the study run? Kunming Hope of Health Hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Patients will get infused with anti-CD19 CAR-NK cells within 1 week after hematopoietic stem cell infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-CD19 UCAR-NK cells | Biological | Enrolled participants are chosen to receive one of three different dose levels of U-CAR-NK cells: Dose level one: 5-10×10^6/kg; Dose level two:1-2×10^7/kg; Dose level three:2-5×10^7/kg. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events(AE) after infusion | The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included. Description, time, classification, and outcome of AE events resulted from the investigational medical product, delivery method, or emergency measures will be recorded in the case report form. | Up to 12 months after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Granulocyte implantation time | Time from hematopoietic stem cell transfusion to peripheral blood granulocyte count >0.5×10^9/L for 3 consecutive days. | Up to 1 month after infusion |
| Platelet implantation time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Li, MD | Kunming Hope of Health Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kunming Hope of Health Hospital | Kunming | Yunnan | 650000 | China |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D015448 | Leukemia, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Time from hematopoietic stem cell transfusion to peripheral blood platelet count >20×10^9/L for 7 consecutive days.
| Up to 1 month after infusion |
| Red blood cell implantation time | Time from hematopoietic stem cell transfusion to peripheral blood hemoglobin count >70g/L. | Up to 1 month after infusion |
| Duration of remission (DOR) | Duration of remission (DOR) refers to the time from the first assessment of CR or PR of the tumor to the first assessment of disease recurrence or progression or death from any cause. | Up to 24 weeks after infusion |
| Disease control rate (DCR) | Disease control rate (DCR) are defined as the percentage of patients who have achieved complete response, partial response or stable disease to a therapeutic intervention in clinical trials of anticancer agents. | Up to 24 weeks after infusion |
| Overall survival (OS) | Overall survival (OS) refers to the time from the time the patient received an infusion of CAR-NK cells until death (from any cause). | Up to 24 weeks after infusion |
| Progression-free survival (PFS) | Progression-free survival (PFS) refers to the time from the start of treatment with CAR-NK cells to the first progression of disease or death from any cause. | Up to 24 weeks after infusion |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |